A Retrospective Randomized Controlled Study Comparing Low-Level Laser Therapy and Ultrasound Therapy for Pain Reduction in Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Compare the difference in mean pain intensity scores in patients undergoing Low-Level Laser Therapy and Ultrasound Therapy for Temporomandibular Disorder before and after therapy.
研究概览
简要总结
Temporomandibular disorders (TMDs) are the most common cause of non-dental orofacial pain, involving the temporomandibular joint (TMJ), masticatory muscles, or associated structures. Globally, TMD is the second most prevalent musculoskeletal pain condition after low back pain. Epidemiological data show a high prevalence of TMD symptoms, particularly among women and Asian populations, with significant disease burden reported in Nepal. Conservative management remains the mainstay of TMD treatment, as evidence supporting surgical intervention is limited and inconclusive.
Among conservative modalities, physical therapies such as ultrasound therapy and low-level laser therapy (LLLT) have gained attention for pain reduction and functional improvement. Ultrasound therapy produces thermal and non-thermal effects that enhance blood flow, reduce muscle spasm, improve tissue extensibility, and promote healing. LLLT, through photobiomodulation, acts at the cellular level by increasing ATP production, reducing inflammatory mediators, enhancing collagen synthesis, and providing analgesic and anti-inflammatory effects.
Although several international studies have evaluated ultrasound and LLLT individually or in combination, limited studies have directly compared their effectiveness in TMD, and no such studies have been conducted in Nepal. Therefore, this study aims to compare the effectiveness of therapeutic ultrasound and LLLT in reducing pain and improving mouth opening in patients with TMD presenting to BPKIHS.
This was a retrospective randomized controlled study conducted at the Department of Oral Medicine and Radiology, College of Dental Surgery, BPKIHS. A total of 46 patients diagnosed with myalgia of masticatory muscles and/or TMJ arthralgia according to DC/TMD criteria were included using purposive sampling. Patients were allocated into two groups: Group A received low-level laser therapy (650 nm wavelength, 2 J/cm² for 3 minutes) and Group B received therapeutic ultrasound (1 MHz, 1.3 W/cm², continuous mode for 5 minutes). Five treatment sessions had been administered over two weeks.
Pain intensity was assessed using the Visual Analogue Scale (VAS) at each visit, while inter-incisal mouth opening was measured using a metallic scale at baseline and at the final visit.
Primary outcome measure was the difference in VAS scores in patients undergoing ultrasound therapy and low-level laser therapy for temporomandibular disorder before and after therapy.
Secondary outcome measures included the difference in inter-incisal mouth opening before and after therapy and the effectiveness of ultrasound therapy and low-level laser therapy in reducing pain in patients with arthralgia and myalgia.
Data were analyzed using SPSS version 11.5. Descriptive statistics were calculated, and inferential tests including independent and paired t-tests (or non-parametric equivalents), ANOVA/Kruskal-Wallis tests, and logistic regression were applied where appropriate. Ethical clearance was obtained from the Institutional Review Committee, BPKIHS with Ref. 20/080/081-IRC, Code no. IRC/2509/023.
详细描述
INTRODUCTION Temporomandibular joint disorders (TMDs), the most common cause of pain of non-dental origin in the oro-facial region, comprise signs and symptoms involving the masticatory muscles, temporomandibular joint or both. The American Academy of Orofacial pain defines temporomandibular disorders (TMDs) as "a collective term that includes a number of clinical problems that involve the masticatory muscles, the Temporomandibular joint (TMJ) and the associated structures". Pain limiting mouth opening, asymmetrical jaw movements, and TMJ sounds are the most common findings in TMDs.
TMD is the 2nd most common musculoskeletal pain in world, with low back pain being the first. About 33% of the population has at least one TMD symptom and 3.6 to 7.0% of the population has TMD with sufficient severity that they desire treatment. Whereas the prevalence of TMD symptoms in Asian adolescents is found to be considerably higher reporting 61.4 % of population having one or more TMD symptom/s. Epidemiological study in Eastern part of Nepal showed TMDs affecting mostly women in the age group of 31-50 years with prevalence of more than 2/3rd among the total study samples.
TMJ pain is considered the most common cause of chronic orofacial pain that is excruciating in nature. There are different types of treatment for TMD. Conservative treatments for TMD include medication, physiotherapy, occlusal splints, self-management strategies, and interventions based on cognitive behavioral approaches. At present, a conservative treatment approach prevails over surgery, given it is less aggressive and usually results in satisfactory clinical outcomes in mild-moderate TMD. In fact, the evidence for the greatest effectiveness of surgical versus conservative intervention to reduce short-term pain in arthrogenic TMD is controversial and inconclusive.
Pharmaceutic therapies have been vastly used in the past 25 years to relieve the syndrome of TMD. The most effective pharmacological agents used to treat TMD include nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, corticosteroids, anxiolytics, muscle relaxants, antidepressants, and anticonvulsants.
The various physical therapy methods used are moist heat, ultrasound, laser, exercises, transcutaneous electrical nerve stimulation (TENS), microwave, and manual therapy. These methods help in decreasing muscular spasms; treatment of contractures; relief and healing of sports-related injuries; relief of pain; increased extensibility and treatment of contractures for collagen tissue (scar tissue) and connective tissues; heating of joint structures; treatment to improve limited joint motion, decrease in joint stiffness, arthritis, peri-arthritis, and bursitis; wound healing and the healing of varicose ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patient diagnosed with myalgia of masseter and temporalis muscles and arthralgia of TMJ based on Diagnostic Criteria for Temporomandibular Disorders DC/TMD.
排除标准
- •Patients who were not willing to participate in the research.
- •Patients who were undergoing treatment or had already undergone treatment for temporomandibular disorders within the preceding three months.
- •Patients who were taking antidepressants, analgesics, or antipsychotic medications.
- •Patients who had structural bony abnormalities of the temporomandibular joint on radiographic examination.
- •Patients with the presence of joint disorders.
- •Pregnant women.
- •Patients with a history of facial trauma or fractures of the facial bones.
- •Patients who presented with severe pain.
- •Patients with severely reduced mouth opening (i.e., less than 10 mm).
研究组 & 干预措施
Low-level laser therapy
Participants in this arm received low-level laser therapy applied to the area of maximum pain in the temporomandibular region. The therapy was delivered using a single-probe laser emitting infrared radiation at a wavelength of 650 nm, with an energy density of 2 J/cm² and an output power of 80 mW for 3 minutes per session. Treatment was administered over five sessions.
干预措施: Low-Level Laser Therapy (Device)
Ultrasound therapy
Participants in this arm received therapeutic ultrasound applied to the affected temporomandibular region. Ultrasound was delivered at a frequency of 1 MHz and an intensity of 1.3 W/cm² in continuous mode for 5 minutes per side per session. Treatment was administered over five sessions.
干预措施: Ultrasound therapy (Device)
结局指标
主要结局
Compare the difference in mean pain intensity scores in patients undergoing Low-Level Laser Therapy and Ultrasound Therapy for Temporomandibular Disorder before and after therapy.
时间窗: From enrollment to the end of treatment at 2 weeks
Description: Pain intensity was assessed using the Visual Analogue Scale (VAS). The VAS consisted of a 10-cm horizontal line, with the left end representing "no pain" (0) and the right end representing "worst imaginable pain" (10). Higher scores indicated greater pain intensity. Participants were instructed on the use of the scale and were asked to mark a single point on the line corresponding to their current level of temporomandibular joint pain. Pain scores were recorded at baseline (pre-therapy) and at subsequent visits during the treatment period. The change in pain intensity was calculated by comparing pre- and post-therapy scores and was expressed as percentage reduction in VAS score.
次要结局
- Compare the difference in mean inter-incisal mouth opening in patients undergoing Low-Level Laser Therapy and Ultrasound Therapy for Temporomandibular Disorder pre- and post-therapy(From enrollment to the end of treatment at 2 weeks)
- Compare the effectiveness of Low-Level Laser Therapy and Ultrasound Therapy in reducing pain in patients with temporomandibular joint arthralgia and myalgia of the masseter and temporalis muscles.(From enrollment to the end of treatment at 2 weeks)
研究者
Akunchan Shrestha
Senior Resident
B.P. Koirala Institute of Health Sciences